Esomeprazole Magnesium
- Product NDC
- 71335-2505
- 11-digit product format
- 713352505
- Labeler code
- 71335
- Product ID
- 71335-2505_5a4dabd2-94d0-4eea-828d-0fb0534d3074
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213859
- Marketing category
- ANDA
- Marketing start
- 2023-08-15
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606726 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2505-1 | 71335250501 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-1) | 2024-12-05 | No | No | Current |
| 71335-2505-2 | 71335250502 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-2) | 2024-12-12 | No | No | Current |
| 71335-2505-3 | 71335250503 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-3) | 2024-09-27 | No | No | Current |
| 71335-2505-4 | 71335250504 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-4) | 2024-12-12 | No | No | Current |
| 71335-2505-5 | 71335250505 | 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-5) | 2024-12-12 | No | No | Current |
| 71335-2505-6 | 71335250506 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-6) | 2024-12-12 | No | No | Current |
| 71335-2505-7 | 71335250507 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-7) | 2024-12-12 | No | No | Current |
| 71335-2505-8 | 71335250508 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-8) | 2024-12-12 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Esomeprazole Magnesium | Bryant Ranch Prepack | 2024-12-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |